The research focuses on IPR regulation in biobanks and deals with different types of biobanks and their working methods and structures. The main IPRs in biobanks are discussed (mostly concerning copyright and patent law). The research also deals with open biobanks, where samples and data are available freely.
Letzte Änderung: 04.02.19
The research question is whether patenting in the field of biotechnology has a negative effect on innovation. Critics argue that patenting DNA sequences, proteins, amino acids and other macromolecules has chilling impact on research. The grant of a patent on a genetic sequence, e.g. single nucleotide pylymorphism, might limit the ability of other researchers to use that data for further research. As things stand now, once a single industrial application is shown in the patent application, the patentee can claim control over other uses of the patented gene as well . In the case of biobanks, such patents would lead to a condition that no other biorepository could use the same gene sequence for its researches. Research exemptions may alleviate the cost burden on researchers wanting to carry out studies using the tests for principally research purposes. TRIPS, in Article 30, states that members can provide limited exceptions to the exclusive rights conferred by a patent. Article 8 of TRIPS permits members to adopt measures necessary to protect public health and nutrition and to promote the public interest in sectors of vital importance to their socioeconomic and technological development. Some countries have adopted research exceptions granting a limited right to researchers to experiment on a patented invention without having to pay royalties to the patentee. But this exception is limited to non-commercial experiments and could never be used for commercial purposes. Also, uncertainties about the scope of the research exception clause in the case of research dealing with genetic material, can minimize such use possibilities. This environment creates significant uncertainty for researchers, who may become hesitant to undertake projects where they need to rely on ill-defined exemptions.
From this perspective, the thesis will also focus on open access (as an analogy to open source) in the biobanks, as well as the possible use of Creative Commons licenses in this field. Free flow of information is very important for researchers and society as such. The thesis analyzes ‘open world’ biobanks, also known as open-source or open-science biobanks. When applied to data acquired through biomedical research, the terms ‘open source biotechnology’ or, alternatively, ‘open science’ mean that data from the project is released rapidly into the public domain, subject to certain conditions, including a requirement that data users not exercise their intellectual property rights in a way that would preclude other users’ access to the basic data. One of the main goals of the thesis is to show a positive effect of sharing genomic data without any restrictions, both for science and for society.
The research adopts an empirical approach, based on questionnaires and semi-structured interviews, and also quantitative methods: analysis of relevant literature and important case studies.
Jurate Breimelyte
Dr. Roberto Romandini
Methodische Grundsatzfragen des Innovationswettbewerbs
